Analytical Equipment Qualification specialist / Project Lead

Johnson & Johnson is currently seeking a Equipment Life Cycle management (ELM) Specialist to join our Biotherapeutics lab services department located in Leiden. Imagine your next role as an Analytical Equipment Qualification specialist / Project Lead who has demonstrable experience and affinity with leading equipment introduction projects in a GMP environment.

Roles and responsibilities: Lead end-to-end implementation of lab systems across teams, from standalone analytical equipment to global platform projects. Be responsible for multiple multidisciplinary equipment introduction, relocation, requalification and decommissioning projects concurrently, from initiation to closure. Define project scope, budgets, resourcing, planning, and stakeholder management, and monitor execution to meet agreed timelines.

Document and standardize administrator, installation, and maintenance procedures; ensure compliance with USP, GAMP, GMP, and ERES. Collaborate on Lab Systems initiatives with the global organization and maintain the equipment validation master plan (inventory, qualification status, and related data). Engage with vendors to understand and implement new technology versions, ensuring reliability and performance, while coordinating internal and external communications during implementation.

Involved in maintaining the equipment validation master plan for QC equipment (inventory, qualification status, additional information as required). Engages with equipment vendors to understand and implement new versions of technology in service of improving reliability and performance. Oversees communication between internal and external parties during the analytical equipment implementation process.

How to succeed: Master’s degree or bachelor’s degree (HBO) in Life Sciences or highly experienced in a similar position. Proven Project Management skills and experience. Proven work experience in Pharma with GMP and automation skills. Pro-active, works independently, takes actions in the absence of specific instructions, and can write protocols/reports, business correspondence, and procedures. Experience in budgeting, resourcing, planning, and leading projects.

Laboratory Experience is considered a plus. A background with experience with (Computer) System Validation in a GxP environment is considered a plus. Experience with the following softwares is considered a plus: Empower, Softmax pro, SDMS, Deskman, LIMS, 32Karat, Trackwise, Comet and KNEAT. Ability to engage with personnel at all levels within the organization, to build and maintain fruitful relationships. Written and oral communication skills in English.

Dutch is desirable. Planning skills, ability to prioritize multiple commitments. Analytical thinking and (technical) problem-solving. Lean/Six Sigma experience is desirable.

Details: This role offers a very competitive hourly rate. This contract will run for 1 year. Hybrid role - 3 days on-site, 2 days at home. Randstad, as the EMEA Johnson & Johnson talent acquisition partner, is responsible for finding and contracting talent for the contingent roles at Johnson & Johnson. If you are selected for a role you will be engaged or employed by one of the Randstad recruitment companies in EMEA and will not be an employee of Johnson & Johnson.